MAUDE Adverse Event Report: BECTON DICKINSON BD¿ PHLEBOTOMY SHARPS COLLECTOR, 1 QT WITH NEEDLE PORT; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305635
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacturer: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported when using the bd¿ phlebotomy sharps collector, 1 qt with needle port there was no label or missing label information.This event occurred with 5 collectors.The following information was provided by the initial reporter.The customer stated: "there was no label on five products in a carton.".
Additional Manufacturer Narrative
H6: investigation summary: no photos or samples were received.Additional attempt to get more information was made, however, the customer confirmed that no additional information was available.According to the dhr review process, the result showed there were no issues reported as missing label during the manufacturing process of the lot number reported (1268908) under this customer complaint.
Event or Problem Description
It was reported when using the bd¿ phlebotomy sharps collector, 1 qt with needle port there was no label or missing label information.This event occurred with 5 collectors.The following information was provided by the initial reporter.The customer stated: "there was no label on five products in a carton.".

• Brand Name: BD¿ PHLEBOTOMY SHARPS COLLECTOR, 1 QT WITH NEEDLE PORT
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13892095
• Report Number: 2243072-2022-00390
• Device Sequence Number: 1713755
• Product Code: FMI
• UDI-Device Identifier: 00382903056354
• UDI-Public: 00382903056354
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K943139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 305635
• Device Catalogue Number: 305635
• Device Lot Number: 1268908
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2022
• Supplement Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown